Evaluation of the Performance and Safety of a Type I Collagen-Based Medical Device (MD-Small Joints Collagen Medical Device) i the Treatment of RHIZOARTROSIS

NARecruitingINTERVENTIONAL
Enrollment

42

Participants

Timeline

Start Date

November 18, 2024

Primary Completion Date

December 29, 2025

Study Completion Date

March 30, 2026

Conditions
Trapeziometacarpal OsteoarthritisRhizarthrosisMEDICAL DEVICEInfiltrate
Interventions
DEVICE

MD-Small Joints Collagen Medical Device

The infiltrations will be performed using 2.5ml syringes and 26 gauge/13mm needles under complete aseptic conditions. The first 3 infiltrations will be carried out at both intra- and peri-articular levels by injecting MD-Small Joints Collagen Medical Device into the trapeziometacarpal joint until a counter-pressure is felt, preventing further penetration of the liquid; the remaining quantity (usually about 1ml) will be injected at the peri-articular level by retracting the needle tip. The fourth and fifth infiltrations will be performed only at the peri-articular level.

Trial Locations (1)

20135

RECRUITING

ASST Grande Ospedale Metropolitano Niguarda Piazza dell'Ospedale Maggiore,, Milan

All Listed Sponsors
lead

Guna S.p.a

INDUSTRY